FDAClass IIJuly 28, 2021

The MTS Set is a single-use recall

The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a…

Why was The MTS Set is a single-use recalled?

Exposed to freezing temperatures due to refrigerated truck malfunctions

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 20SR08069 UDI: (01)00840861100811 20PR08237 UDI: (01)00840861100811

Product
The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a…
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
5 cases
Distribution
US Distribution to: TX only
Recall date
July 28, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
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